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New preterm formula study: will HMOs help tiny babies grow?

NCT ID NCT04639518

Disease control Sponsor: Société des Produits Nestlé (SPN) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two types of preterm infant formula—one with added human milk oligosaccharides (HMOs) and one without—to see how they affect growth and safety in very small babies. Twenty-eight preterm infants weighing 1.5 kg or less were enrolled. Researchers tracked weight gain, length, and head growth from birth until two months after hospital discharge.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Preterm infant formula (with or without human milk oligosaccharides)
What this could lead to
If successful, this could help doctors choose safer, more effective formulas for preterm babies to support healthy growth.
What could go wrong
This is a small, early-stage study with only 28 infants, so results may not apply to all preterm babies. Formulas are not a cure and only support nutrition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

28 people

The number who actually took part.

Started

Sep 2020

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 10 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent has been obtained from one or both parent(s) /legally acceptable representative (LAR) in accordance with local regulation. 2. Infants' birth weight ≤1500 g and AGA. 3. Infant's gestational age \< 37 weeks. 4. Infant is clinically stable and does not have deteriorating respiratory function after birth. 5. Infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (≤240 hours) of life. Exclusion Criteria: 1. Parent(s) not willing / not able to comply with the requirements of study protocol. 2. Infant is experiencing early onset sepsis. 3. Major congenital or chromosomal abnormality known to affect growth. 4. Liver failure. 5. Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification). 6. Infant who has siblings with diagnosed allergies or intolerances to lactose or cow's milk. 7. Infant's participation in another interventional clinical trial. 8. Infant has already achieved FEF prior to enrolment, using the definition accepted by Neonatal Unit as per standard practice (150 mL/kg/day).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pre-term infant

Contacts and locations

Locations

  • Fakultna nemocnica s poliklinikou Nove Zamky

    Nové Zámky, 940 34, Slovakia

  • Klinika Neonatologii, Szpital Uniwersyteck

    Bydgoszcz, 85-067, Poland

  • Klinikum Nuernberg

    Nuremberg, Germany

  • Univerzitna nemocnica Martin

    Martin, 3659, Slovakia